DeviceClearance

K873986

Substantially Equivalent

BETA-HCG ASSAY

Applicant
Schiff & Co.
Product code
DHA
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
West Cadwell, NJ, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code DHA

product code DHA
Malfunction
1,242
Total
1,242

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.